Neuroenhancement technology has grown out of research and treatments for brain conditions such as Parkinson's and Alzheimer's disease, as well as drugs that have traditionally been used to treat ADHD symptoms. As these technologies are still generally in the research and testing phases, and then still are being used to treat medical conditions, the off-label usage for the purpose of neuroenhancement is currently not being regulated. Also, obtaining or using prescription medications for off-label use is generally going to be considered illegal any unethical in most countries, however there are alternatives such as the use of caffeine that provide certain neuroenhancement effects that are legal and widely available. Transcranial direct current stimulation and deep brain stimulation hardware are currently classified as medical equipment, and the FDA generally does not consider medical equipment as a danger, and therefore does not require it to be reviewed, and the World Health Organization in Geneva, states that medical equipment safety is the responsibility of stakeholders. As far as the actual marketing of the neuroenhancement devices if they are classified as medical devices, the governing bodies of the United States only require a pre-market stage of approval and a marketing clearance and registration when placing the product on the market. Other countries such as Australia, Canada, UK all have three stages of approval, but prohibit any advertisement before the device is completely approved to prevent any misleading advertisement. The requirement in Japan in the pre-market approval phase requires approval and notification, and when placing it on the market the manufacturer needs to get a license, an import license, and a sales notification from the regulatory body. Statistics show that the United States, Europe and Japan manufacture 85% of medical devices in the world and have regulatory systems in place that follow the “Essential Principles of Safety and Performance of Medical Devices.” Also an individual government can adopt a policy of approving devices that are in compliance with the regulations of another country.
There is currently no regulation for consumer versions of these devices, the companies that produce them do not have to provide consumers notice of the possible dangers, nor backup any claims about the effectiveness of their equipment. Many of these current generation of transcranial stimulation devices are marketed as being for entertainment or gaming purposes, so companies have been able to label their products with dubious and often unsubstantiated claims. Scientists that are currently conducting research and testing of neuroenhancement technology are actively campaigning for regulatory bodies to create and enforce regulations for these devices before they are released to consumers. According to the U.S. Food and Drug Administration, medical devices that send electronic product radiation are regulated. Manufacturer should be aware of radiation protection requirements and recommendation for consumers under 21 years of age. They have standards for reporting, performance and recordkeeping before an after their product can be in the market. However, Transcranial stimulation devices are also being created by homebrew communities organized via the Internet. Since the materials are easy to find and the devices are relatively easy to construct, many users are able to construct and attempt to perform the neuroenhancement stimulation on themselves, sometimes leading to dire consequences.
References
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Hogenboom, Melissa. "Warning over Electrical Brain Stimulation." BBC News. BBC News, 23 Aug. 2014. Web. 05 Oct. 2014.
About FDA. (n.d.). Retrieved December 1, 2014, from http://www.fda.gov/AboutFDA/Transparency/Basics/ucm302659.htm